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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALLERGAN (PRINGY) VOLBELLA WITH LIDOCAINE IMPLANT, DERMAL, FOR AESTHETIC USE

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ALLERGAN (PRINGY) VOLBELLA WITH LIDOCAINE IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Catalog Number 94731RX
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Inflammation (1932); Skin Irritation (2076)
Event Date 02/15/2020
Event Type  Injury  
Manufacturer Narrative
Further information regarding event, product, or patient details has been requested. No additional information is available at this time. The event is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event. Clarification: the filler was injected into the patient and is not accessible for return. The syringe was discarded. A review of the device history record has been completed. No deviations or non-conformances noted. This is a known potential adverse event addressed in the product labeling.
 
Event Description
Healthcare professional reported that patient was injected with juvederm® volift¿ with lidocaine, hydrate, and juvederm® volbella¿ with lidocaine were injected in temporal, malar, cheek support, nasojugal and nasogenian grooves. Approximately 7 months later, patient was injected with volbella¿ with lidocaine in lower lip body, nasogenian groove and marionette lines and botox® treatment. Approximately 6 months later, patient was injected with juvederm® volift¿ in lips outline. Approximately 11 months later, patient was injected with volbella¿ with lidocaine in the dark circles and lips outline. Five months later, patient had botox® treatment. Six months later, patient was injected with juvederm® volbella¿ with lidocaine in dark circles and lip outline. Two months later, patient was injected with juvederm® volbella¿ with lidocaine in nasogenian groove and marionette bars. Approximately 11 months later, patient was injected with juvederm® voluma¿ with lidocaine in cheek. Approximately 2 months later, patient was injected with juvederm® volbella¿ with lidocaine in lips in superior nasogenian groove, lips and marionette bars with juvederm ® volite¿ in the periocular. Approximately a year later, patient was injected with juvederm® volbella¿ with lidocaine in nasogenian groove and marionette bars with juvéderm® voluma¿ with lidocaine and two different kinds of non allergan devices were injected in dark circle areas and jaw angle. Approximately 4 months later, patient experienced developed facial edema on the cheeks, perocular, and oral mucosa, more so on the lips. Eight months later, patient was treated with intramuscular betamethasone. Four days later, patient then prescribed 3-day medrol dose pack. Eleven days later, patient had ultrasound that showed granulomas in nasolabial region (not confirmed by biopsy), edema with hypoechoic fluid bundles in malar region, fibrous scar tissue, and superficial phlebitis of the vein. On the same day, patient was treated with 750u of hyaluronidase. Five days later, patient was treated with kenacort and given clarithromycin prescription. Symptoms are partially solved. This is the same event and the same patient reported under mdr id # 3005113652-2020-00725 (allergan complaint #(b)(4)), mdr id # 3005113652-2020-00727 (allergan complaint #(b)(4)),mdr id # 3005113652-2020-00728 (allergan complaint #(b)(4)), mdr id # 3005113652-2020-00729 (allergan complaint #(b)(4)),mdr id # 3005113652-2020-00730 (allergan complaint #(b)(4)),mdr id # 3005113652-2020-00765 (allergan complaint #(b)(4)),mdr id # 3005113652-2020-00723 (allergan complaint #(b)(4)),mdr id # 3005113652-2020-00724 (allergan complaint #(b)(4)). This mdr is being submitted for the 2nd suspect product, juvederm® volbella¿ with lidocaine.
 
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Brand NameVOLBELLA WITH LIDOCAINE
Type of DeviceIMPLANT, DERMAL, FOR AESTHETIC USE
Manufacturer (Section D)
ALLERGAN (PRINGY)
route de promery
zone artisanale de pre-mairy
pringy 74370
FR 74370
Manufacturer (Section G)
ALLERGAN (PRINGY)
route de promery
zone artisanale de pre-mairy
pringy 74370
FR 74370
Manufacturer Contact
michelle burgess
12331-a riata trace parkway
building 3
austin, TX 78727
7372473605
MDR Report Key10960289
MDR Text Key219978489
Report Number3005113652-2020-00726
Device Sequence Number1
Product Code LMH
Combination Product (y/n)Y
Reporter Country CodeCO
PMA/PMN Number
P110033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 12/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/31/2017
Device Catalogue Number94731RX
Device Lot NumberV15LA50418
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/09/2020
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/07/2020 Patient Sequence Number: 1
Treatment
HYDRATE¿, JUVÉDERM® VOLIFT¿ WITH LIDOCAINE
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